Dubin 1996.
Methods | Allocation: randomised ‐ randomisation table. Blinding: double ‐ identical ampules, staff administering medication not blinded, assessors blind. Duration: 6 days ‐ preceded by 24h washout (only data from first 72 hours used). Setting: single centre. | |
Participants | Diagnosis: schizophrenia (52), bipolar manic (9) (DSM‐III). N=61. Age: mean ˜ 35 years, range 18‐65. Sex: ˜27 M, ˜31 F. Inclusion : BPRS score of 6/7 in >2 prespecified symptom categories. History: admitted as psychiatric emergency, healthy, drug sensitivity, not pregnant or lactating, no co‐existing mental illness. | |
Interventions | 1. Loxapine: dose mean 75.5 mg/day IM, range 25‐175 mg/day IM. N=30.
2. Thiothixene: dose mean 31 mg/day IM, range 20‐60 mg/day IM, N=31. IM for first 24 hours, then oral. IM injections every 30 minutes as needed, until BPRS reduced or sedation occurred. Chloral hydrate, trihexyphenidyl/benztropine as required. |
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Outcomes | Global effect (sedation, requiring further injections).
Dropped from study. Unable to use ‐ Global effect: CGI (no data). Mental state: BPRS (no SD). Side effects: (only data for 5 day oral phase available). Physiological measures: BP, pulse (no data). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | A ‐ Adequate |